MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO CENTRIFUGAL SYSTEM; SARNS CENTRIFUGAL SYSTEM

Model Number 9490

Device Problem Low Battery (2584)

Patient Problem No Patient Involvement (2645)

Event Date 11/03/2014

Event Type  malfunction  

Event Description

It was reported that during the use of the device for a non-clinical activity, the centrifugal batteries used as a backup for the customer's system-1, were not holding a battery charge.The perfusionist (ccp) was checking the unit when they found the issue.This unit is primarily used as back-up.There was no patient involvement.

Manufacturer Narrative

The field service representative (fsr) replaced two 12volt batteries and performed a release test successfully.The unit operated to manufacturer specification and was returned to clinical use.The suspect batteries were returned to the manufacturer for further evaluation.The laboratory evaluation confirmed the complaint.One of the two batteries was received in a severely discharged condition and will not properly charge.As a pair, they are too weak to support the centrifugal control module.Conductance measurements were not available for the first battery initially, due to the low voltage.Conductance value of the second battery was 83 siemens (above minimum specification of (b)(4)).These batteries were within their three year service life as service history shows they were installed on (b)(4) 2012.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: TERUMO CENTRIFUGAL SYSTEM
• Type of Device: SARNS CENTRIFUGAL SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4307554
• MDR Text Key: 16856664
• Report Number: 1828100-2014-01006
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K902198
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9490
• Device Catalogue Number: 9490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1